X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent

Manufacturer
X-PROUSA LLC
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:59

Label at a glance#

ProductX-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 72%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease.
  • Recommended for repeated use 

Warnings

WARNINGS SECTION

  • For external use only.
  • Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • Do not use on children less than 2 months of age.
  • Do not use on open skin wounds

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes, ears, and mouth.
  • In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces.
  • Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

Store between 15-30°C (59-86°F) 
Avoid freezing and excessive heat above 40°C (104°F )

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Tocopherol Acetate, Fragrance(s)

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:118ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:240ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

Package Labeling:470ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

Package Labeling:950ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle6Bottle6

Package Labeling:3800ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle7Bottle7

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN1
2277550ethanol 0.72 ML/ML Topical GelSCD1
2277550ethanol 72 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79490-001-01X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent30 mL in 1 BOTTLEGEL301
79490-001-02X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent60 mL in 1 BOTTLEGEL601
79490-001-04X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent118 mL in 1 BOTTLEGEL1181
79490-001-08X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent240 mL in 1 BOTTLEGEL2401
79490-001-16X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent470 mL in 1 BOTTLEGEL4701
79490-001-32X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent950 mL in 1 BOTTLEGEL9501
79490-001-38X-PROUSA Antiseptic Hand Sanitizer Gel, Clean and Fresh Scent3800 mL in 1 BOTTLEGEL38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79490-001X-PROUSA ANTISEPTIC HAND SANITIZER GEL, CLEAN AND FRESH SCENT (ALCOHOL) GEL [X-PROUSA LLC]1Legacy NDC, 7 package rows20200827_adcd4e73-df2a-ba88-e053-2a95a90a7408.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79490-00179490-001-01, 79490-001-02, 79490-001-04, 79490-001-08, 79490-001-16, 79490-001-32, 79490-001-38

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
adcd4fc7-c3ff-fc8e-e053-2a95a90a7e1fadcd4e73-df2a-ba88-e053-2a95a90a74082020-08-26WarningsExact identifier
spl id: adcd4fc7-c3ff-fc8e-e053-2a95a90a7e1f
spl set id: adcd4e73-df2a-ba88-e053-2a95a90a7408

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.